IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT06704542 para Trasplante de células madre hematopoyéticas alogénicas, Diabetes mellitus, Impaired Fasting Glucose está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation 1000
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06704542 es un estudio observacional para Trasplante de células madre hematopoyéticas alogénicas, Diabetes mellitus, Impaired Fasting Glucose. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de noviembre de 2024 hasta completar 1000 participantes. Dirigido por Ruijin Hospital, se espera que finalice el 1 de abril de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 26 de noviembre de 2024.
Resumen
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Descripción detallada
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important means of treating a variety of hematologic disorders. With the progress of HSCT technology, especially the research on haploidentical transplantation (HID-HSCT), the range of donor choices for hematological patients has been expanded, and theoretically, the era of "everyone has a donor" has been reached, which has increased the chances for...Mostrar más
Título oficial
A Study of the Impact of Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation Donors on Recipients' Post-Transplant Survival Outcomes: A Multicenter Retrospective Cohort Study Based on HIS Data
Condiciones médicas
Trasplante de células madre hematopoyéticas alogénicasDiabetes mellitusImpaired Fasting GlucoseOtros ID del estudio
- RJBMT-07
Número del NCT
Inicio del estudio (real)
2024-11
Última actualización
2024-11-26
Fecha de finalización (estimada)
2025-04
Inscripción (prevista)
1000
Tipo de estudio
Observacional
Estado general
Aún no recluta
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Case Group patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose ≥6.1 mmol/L or HbA1c ≥5.7% | N/A |
Control Group patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose \<6.1 mmol/L; HbA1c \<5.7% (if available) | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Overall Survival (OS) | Patient's overall survival time since hematopoietic stem cell transplantation | One year-overall survival since hematopoietic stem cell transplantation |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Non-relapse Mortality (NRM) | NRM after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Relapse-free Survival (RFS) | RFS after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Event-free Survival (EFS) | EFS after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Graft versus Host Disease (GvHD) incidence | GvHD incidence after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
GvHD and Relapse-free Survival (GRFS) | GRFS incidence after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Cumulative Incidence Rate (CIR) | CIR after hematopoietic stem cell transplantation | One year since hematopoietic stem cell transplantation |
Graft Time of Different Cell Subpopulation | Graft Time of Platelet, Neutrophil | One year since hematopoietic stem cell transplantation |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto, Adulto mayor
Criterios de sexo
Todos
Patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) between March 2019 and March 2024;
Donor had fasting blood glucose and/or HbA1c records
Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2
Survived at least 12 weeks after HSCT
Voluntarily signed the Informed Consent Form
Had appropriate organ function;
Laboratory results within 7 days prior to HSCT met the following criteria:
- Aspartate aminotransferase (AST) ≤ 3-fold (upper limit of norma, ULN);
- Alanine aminotransferase (ALT) ≤ 3x ULN;
- Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;
- Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
- Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
- Active autoimmune diseases such as SLE, rheumatoid arthritis, etc.
- Active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any Grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) Functional Class, or a history of myocardial infarction in the 6 months prior to screening;
- Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);
- HIV infection, or chronic infection with hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV-positive) that cannot be controlled by medications;
- Patients with other uncured tumors
- Patients with neurological or psychiatric disorders
- Patients who were unable to understand or comply with the research protocol or are unable to sign the Informed Consent Form
Ruijin HospitalParte responsable del estudio
Hu Xiaoxia, Investigador principal, Director of the Center for Translational Medicine, Ruijin Hospital
Contactos centrales del estudio
Contacto: Xiaoxia Hu, (86) 13795437259, [email protected]
6 Centros del estudio en 1 países
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Weijie Cao, Contacto, [email protected]
Hubei
Tongji Hospital of Huazhong University of Science and Technology, Wuhan, Wuhan, Hubei, China
Yang Cao, Contacto, [email protected]
Shanghai Municipality
Li Quan Hospital, Shanghai, Shanghai Municipality, China
Chun Wang, Contacto, [email protected]
Ruijin Hospital of Shanghai Jiaotong University, Shanghai, Shanghai Municipality, China
Xiaoxia Hu, Doctor, Contacto, (86) 021-64370045, [email protected]
Zhejiang
The First Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Yanmin Zhao, Contacto, [email protected]
Hospital of Hematology of the Chinese Academy of Medical Sciences, Tianjin, China
Yawei Zheng, Contacto, [email protected]